The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

@ujay68 @jeneralist I agree it's dysfunctional but I think it's about as simple as the CEO says. In pharma development and trials are very expensive, and most candidates don't pass for one reason or another (don't work well enough, bad side effects, etc). If it costs an average US$100M (rough guess) to develop and bring a drug through trials, and 9/10 fail, what do they need to make from the one that works? It itself may only cost $100M but the other $900M needs to come from somewhere.

@ujay68 @jeneralist The consequence of that is the direct cost of manufacturing and delivering a drug could be $1 but that $900M plus some interest on debt or return to investors needs to get spread across whatever it is that they can sell (about $0.10 per dose if you could give it to every person in the world). One way to reduce the overhead of this whole system is to shift more fundamental research to government-funded labs, but of course the US in the process of gutting those as well.

@jeneralist

$&#&@% death cult enagelical Christians and their crazed belief that god micromanages who gets infected

@jeneralist

»In August of 2025, following the successful completion of the Phase 3 efficacy trial in which mRNA-1010 met all pre-specified primary endpoints, Moderna held a pre-submission meeting with CBER [Center for Biologics Evaluation and Research]. CBER requested that supportive analyses be included … Moderna provided the additional analyses … At no time in the pre-submission written feedback or meeting did CBER indicate that it would refuse to review the file.«

https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA

@jeneralist So frustratingly corrupt that they halt studies rather than going to court or abroad.

@jeneralist
An opportunity for Moderna's German competitor, BioNTech (which also develops mRNA vaccines), perhaps

@Mikal @jeneralist

They 100% could apply for approval in Europe or Canada but they won't because without access to the US market their isn't enough profit for them... and companies like Moderna don't care about people, they only care about profit.

Europe, Canada, et al need to force the issue by changing patent law (at least for medical patents but honestly it would be best to cover all patents) to include a 'use it or lose it' clause. If companies don't pursue approval Government's should have the right to step in and use the companies patents to develop the drugs themselves.

@mirth @ujay68 @jeneralist That figure is pretty far off. The costs of trials in the US total up to around $550mus on the low end. $100mus would be very affordable across the whole process.

@mirth @ujay68 @jeneralist Executive bonuses, starting at the director level.

@jeneralist Since Moderna is a multinational company, they should just wind down all operations in the US, and refocus their research in Canada and/or Europe.

And maybe that is what they are quietly doing already.

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

@drwho @ujay68 @jeneralist Yes more just trying to put in context why the cost to develop and approve one drug is not the only underlying cost the company has to cover to stay solvent.

@drwho @ujay68 @jeneralist Generally agreed that bonuses don't really achieve what they are advertised to, though how much difference to the finances would that make in the case of a company like Moderna?

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

@jeneralist @EndicottAuthor Yup. With a side of shakedown as a distraction.

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.

@crazyeddie
Yeah. There are shades of both. We have the obviously inept senate PLUS the obviously unhinged Caligula destroying a world leading economy for no gain (or negative gains due to petty grievances).

The FDA decided not to even review Moderna's mRNA flu vaccines for approval, even though the studies the FDA would be reviewing were conducted the way the FDA told Moderna to do them.

Now #Moderna expects that none of its other #mRNA #vaccines will be reviewed, and has halted studies on vaccines for EBV, HSV, and shingles.

A lot of people with herpes would be angry if they found out.

A lot of people who have family members with #MS -- now thought to be caused in part by EBV -- will be livid.